The present invention relates to apparatus and methods for introducing a needle into a body. More particularly, the invention relates to apparatus and methods for introducing a needle into a body in a particular orientation and in a stable manner.
Many medical procedures are undertaken through small tracts formed within a patient""s tissue. These procedures are minimally invasive. In order to form the tract running from outside of the patient to a target within the patient, a probe typically is inserted in the initial stages of a procedure. This probe will run from the surface of the patient""s skin to the target. Later in the procedure, this initial insertion can be enlarged to accommodate other medical devices necessary for the procedure.
Typically, inserting the probe is a time-consuming procedure. The probe must be positioned properly, typically under the guidance of an energy emitting medical device, such as an x-ray emitting device. X-ray energy passes through the patient""s body and differentially impinges on a fluoroscope screen, exciting fluorescent material, such as calcium tungstate, to create a screen display of the body and probe. The probe is visualized on the fluoroscope as it enters the patient on the display of the medical device. This probe can appear on the screen because it does not allow the energy to pass through it (i.e., it can be opaque).
The present invention allows for the positioning and insertion of a probe, such as a needle, into a patient. A medical professional manipulates devices according to the invention such that a properly aligned device will properly align an entry needle with a target in the patient""s body. Some of the advantages of these devices include shortening the length of a procedure, allowing for a more precise positioning of an entry needle which can, for example, reduce trauma to tissue, and stabilizing the entry needle during placement. Specific embodiments can have these and other advantages described below.
In one aspect of the invention, a needle guiding apparatus includes a base defining an opening extending therethrough; a guide assembly including at least one passage and being disposed within the opening; and an imaging sight disposed adjacent at least one passage. The guide assembly is rotatable about at least one axis
This aspect or any of the other aspects of the invention can have any of the following features. The guide assembly can include a first transmission element between a first location within the opening and a second location remote therefrom. The first transmission element can be for transferring angular movement between the second location and the first location, and the movement at the first location can occur about a first one of the axes. The first transmission element can include a first pulley proximate the first location and disposed coaxially with the first axis of rotation and/or can further include a guide shaft defining at least a portion of the at least one passage. Also, the first transmission element can include a belt for transferring angular movement between the first location and the second location and/or can include a control shaft connected to a second pulley proximate the second location. The needle guiding apparatus also can include a lock for preventing movement of the first transmission element.
The guide assembly can include a second transmission element for transferring angular movement about a second one of the axes. The second transmission element can include an adjustment rod rotatable about the second axis extending through the adjustment rod. The imaging sight can include a radiopaque core of the adjustment rod. The imaging sight can include at least two parallel bars disposed within the adjustment rod. The needle guiding apparatus can include a lock for preventing movement of the adjustment rod. The first axis and the second axis can be substantially perpendicular. The imaging sight can include a radiopaque band disposed within the base. The guide assembly can include an adjustment rod. The adjustment rod can be rotatable about an axis extending through the adjustment rod and/or can be rotatable about an axis extending through the passage.
The guide assembly can include a turret disposed within the opening. The turret can include an adjustment rod. The turret can be rotatable about an axis extending through the opening, and/or the adjustment rod can be rotatable about an axis extending through the adjustment rod. The guide assembly can include a guide needle. The guide assembly can include a ball and socket joint disposed within the base and can further include a guide shaft defining a portion of the passage and/or can further include a control arm connected to the guide assembly and/or can further include a second ball and socket joint connected to the control arm, thereby to replicate the movement of the second ball and socket joint at the guide assembly. The second joint can be capable of locking into a position.
The imaging sight can be disposed coaxially about at least one passage, and/or the imaging sight can include a ring, and/or the imaging sight can include at least one cross-hair. The imaging sight can include a material that is detectable with a fluoroscope, and the material that is detectable with a fluoroscope can include a radiopaque material. The guide assembly can include at least two of the passages, and the passages can be disposed at known angles relative to the base. The needle guiding apparatus can include at least one clamp for attaching the apparatus to a fixed surface. The guide assembly can be capable of locking into a position. At least two of the axes about which the guide assembly rotates can be substantially perpendicular
The needle guiding apparatus can include an entry needle, the needle capable of inserting through the passage. Any entry needle can include radiopaque cross-hairs to aid with aligning a needle guiding apparatus and/or the entry needle. The entry needle can include a first assembly that includes a housing, a stylet extending into the housing and biased towards a distal end of the entry needle, and a hub adjacent the housing at a proximal end of the entry needle and in connection with the stylet, and the entry needle can include a second assembly that includes a cannula surrounding the stylet. The first assembly and the second assembly can seal together and can be separable. The hub can be movable from a first position to a second position, the hub in the first position indicating that the entry needle is impeded by a tissue and the hub in the second position indicating that the entry needle is not substantially impeded by the tissue. The stylet can include a blunt edge at its distal end, and/or the cannula can include an angled edge at its distal end, and/or the stylet can include an angled edge at its distal end, and/or the cannula can include a blunt edge at its distal end. The entry needle can include a connector connected with the cannula for attaching a medical device to the entry needle.
The entry needle can include an inner needle coaxially surrounded by a cannula having an outer wall defining a lumen. The cannula can have an opening in the outer wall proximate a distal end of the entry needle and a branch proximate a proximal end of the entry needle, the inner needle including a notch. The inner needle can be rotatable from a first position to a second position, the notched inner needle in the first position allowing communication between the opening and the branch and the notched inner needle in the second position preventing communication between the opening and the branch. The branch can be capable of attaching to a suction device.
The entry needle can include an electromagnetic energy sensor. The entry needle can include a chemical sensor. The guide assembly can be constructed such that it does not protrude past at least one side of the base.
In another aspect of the invention, a method for aiming a needle guiding apparatus includes the steps of providing a needle guiding apparatus that includes a base having an opening, a guide assembly defining at least one passage and disposed within the opening, the guide being rotatable about at least one axis, and an imaging sight disposed adjacent the at least one passage; aligning the imaging sight with at least a portion of a target, and with an energy source; and viewing the sight on a display. The providing step can include providing a needle guiding apparatus that includes an imaging sight that can be ring of radiopaque material, a bar of radiopaque material, a cross-hair of radiopaque material, cross-hairs of radiopaque material, perpendicular bars of radiopaque material, and/or a diamond shape of radiopaque material, and combinations thereof. The viewing step can include viewing the imaging sight on the display, the imaging sight appearing to surround at least the portion of the target and at least a portion of the guide assembly, thereby indicating proper alignment. The guide assembly can include a guide shaft, and the viewing step can include viewing the imaging sight on the display, the imaging sight appearing to surround the guide shaft and at least the portion of the target, thereby indicating proper alignment.
In another aspect of the invention, a needle guiding apparatus includes a base defining an opening extending therethrough; a guide assembly including a turret rotatably mounted in the opening and an adjustment rod rotatably mounted in the turret, the guide assembly including at least one passage therethrough; and an imaging sight disposed adjacent at least one passage. The turret can include a groove for interlocking with pins from the base, thereby to allow rotation of the turret within the base. Alternatively, the turret can be associated with the base using a friction fit, thereby to allow rotation of the turret within the base. The guide assembly can be constructed such that it does not protrude beyond at least one side of the base.
In another aspect of the invention, a needle guiding apparatus includes a base including a socket; a guide assembly including at least one passage therethrough and including a ball articulable within the socket and a guide shaft proximate the ball; and an imaging sight disposed adjacent at least one passage. The needle guiding apparatus also can include a connecting rod in operable connection with the guide assembly and with a mechanism, the mechanism being remote from the guide assembly, thereby to replicate movements of the mechanism at the guide assembly. The mechanism can include a base assembly that includes a socket, a ball being articulable in the socket, and a shaft proximate the ball. The needle guiding apparatus also can include a lock, thereby to prevent movement of the guide assembly. The base can include an opening extending therethrough and the guide assembly can be disposed within the opening.
In another aspect of the invention, a needle guiding apparatus includes a base, a dome, and a guide assembly that includes a stop and defines a passage, such that the guide assembly is positionable at various locations through the dome and the guide assembly does not protrude beyond at least one surface of the base. The dome can include an imaging sight.
In another aspect of the invention, a needle guiding apparatus includes a base defining an opening extending therethrough; a guide assembly including a turret rotatable within the opening, the turret defining at least two passages therethrough, the passages being at known angles of entry relative to the base; and an imaging sight adjacent at least one passage.
In another aspect of the invention, a needle guiding apparatus includes a base defining an opening extending therethrough; a guide assembly including a guide needle including a passage therethrough, the guide needle being rotatable about an axis that extends through the base and is substantially perpendicular to the guide needle; and an imaging sight adjacent the passage. The needle guiding apparatus also can include at least one driving bar for inserting an entry needle through the passage and/or can include at least one bar guide for sliding at least one driving bar along a predetermined range of motion. The needle guiding apparatus also can include at least one driving bar for applying force to the guide assembly and/or include at least one bar guide, such that at least one driving bar is affixed to the at least one bar guide and that applied force is conveyed from the at least one driving bar to the guide assembly.
In another aspect of the invention, a needle guiding apparatus includes a base defining an opening extending therethrough; a guide assembly including an adjustment rod rotatable about an axis extending through the adjustment rod and a guide needle extending through the adjustment rod and defining a passage extending therethrough; and an imaging sight adjacent the passage. The needle guiding apparatus also can include a lock for preventing movement of the alignment rod. The needle guiding apparatus also can include at least one driving bar associated with an entry needle for applying force to the entry needle, the entry needle passing through the passage, and/or at least one bar guide for sliding at least one driving bar along a predetermined range of motion. The needle guiding apparatus also can include at least one driving bar for applying force to the guide assembly, and/or at least one bar guide, such that at least one driving bar is affixed to the at least one bar guide and that applied force is conveyed from the at least one driving bar to the guide assembly.
In another aspect of the invention, an entry needle can include a first assembly that includes a housing, a stylet extending into the housing and biased towards a distal end of the entry needle, and a hub adjacent the housing at a proximal end of the entry needle and in connection with the stylet. The entry needle also can include a second assembly that includes a cannula surrounding the stylet. The first assembly and the second assembly can seal together and can be separable. The hub can be movable from a first position to a second position, the hub in the first position indicating that the entry needle is impeded by a tissue and the hub in the second position indicating that the entry needle is substantially unimpeded by the tissue. The stylet can include a blunt edge at its distal end, and/or the cannula can include an angled edge at its distal end, and/or the stylet can include an angled edge at its distal end, and/or the cannula can include a blunt edge at its distal end. The entry needle also can include a connector connected with the cannula for attaching a medical device to the entry needle.
In another aspect of the invention, a needle guiding apparatus includes a position holding device; a needle disposed within and coaxially with the position holding device; a front aiming device proximate a distal end of the needle guiding apparatus and disposed coaxially about the needle; and a rear aiming device proximate a proximal end of the needle driving apparatus and disposed coaxially about the needle. The position holding device can include a needle. At least a portion of the position holding device can be radiopaque. At least a portion of the needle can be radiopaque. At least a portion of the front aiming device can be radiopaque. The front aiming device can include a circular portion. At least a portion of the rear aiming device can be radiopaque. The rear aiming device can include at least one cross-hair. The needle guiding apparatus also can include a trigger for delivering the needle. The needle guiding apparatus also can include a cannula having an outer wall defining a lumen and being coaxially disposed about the needle. The cannula can have an opening in the outer wall proximate the distal end and a branch proximate the proximal end, and the needle can include a notch. The needle can be rotatable from a first position to a second position, the notched needle in the first position allowing communication between the opening and the branch and the notched needle in the second position preventing communication between the opening and the branch. The branch can be capable of attaching to a suction device. A cannula can include an electromagnetic energy sensor. A cannula can include a chemical sensor.
In another aspect of the invention, a method of aiming a needle guiding apparatus includes the steps of providing a needle guiding apparatus that includes a position holding device, a needle disposed within and coaxially with the position holding device, a front aiming device proximate a distal end of the needle driving apparatus and disposed coaxially about the needle, and a rear aiming device proximate a proximal end of the needle driving apparatus and disposed coaxially about the needle; aligning a distal end of the needle with a target; aligning an energy source with an axis of the needle and the target; and aligning the distal end of the needle, the center of the front aiming device, and the center of the rear aiming device with the target.